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| Name | Class |
|---|---|
| Medela AG | INDUSTRY |
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Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants
Insufficient Mothers Own Milk (MOM) has its origins during the first 14 days postpartum, a critical window that includes secretory activation (SA; milk coming in; lactogenesis II) and the achievement of coming to volume (CTV; providing 500 mLs/day of MOM by day 14 postpartum). For all lactating mothers, SA must be achieved for lactation to continue, and CTV predicts provision of MOM through to neonatal intensive care unit (NICU) discharge in preterm very low birth weight (VLBW; <1500 g birth weight) infants. For this study, we posit that alternate breast pump suction patterns (BPSP; suction rate, intensity, and rhythm) may facilitate achievement of CTV in mothers who have achieved SA, but whose daily pumped MOM volumes indicate a high risk of not achieving CTV. Therefore, the overall objective of this study is to compare the clinical effectiveness of three different breast pump suction patterns on lactation outcomes, including achievement of SA, among pump dependent mothers of critically ill infants who demonstrate faltering lactation after achievement of SA. At 6-8 days postpartum, 90 pump dependent mothers of critically ill infants who have achieved SA but demonstrate faltering lactation (<350 mLs/day pumped MOM volume), will be randomized to use one of three different BPSPs with two groups having alternative BPSPs and one group using the current practice standard for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Pump Suction Pattern 1 | Active Comparator |
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| Breast Pump Suction Pattern 2 | Active Comparator |
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| Breast Pump Suction Pattern 3 | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Pump suction pattern | Behavioral | Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Pumped milk volume | Daily volume of milk pumped daily | Days 1-15 post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of secretory activation | Whether sodium level < 20 is maintained | Days 1-15 post-partum |
| Maternal perceptions of comfort, effectiveness, efficiency, and convenience | Survey will be used to collect mother's perception of comfort, efficiency, and convenience |
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Inclusion Criteria:
Exclusion Criteria:
Must be able to bear children and produce breast milk.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Parker, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida | Gainesville | Florida | 32504 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Nov 16, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2023 | Nov 16, 2023 | ICF_001.pdf |
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This study will use a randomized control trial design with 3 arms to compare the clinical effectiveness of three different breast pump suction patterns (BPSP) on lactation outcomes among pump dependent mothers of critically ill infants who demonstrate faltering lactation on day 6-8 postpartum. Mothers identified as having faltering lactation will be randomly assigned to one of 3 groups; (1) BPSP1, (2) BPSP 2, and (3) Standard BPSP.
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| Day 15 post-partum |
| Proportion of infant feeds consisting of mother's own milk . | Proportion of feeds consisting of mother's own milk for first 15 days, infant discharge, as well as 3 and 6 months | Days 1 post-partum until 6 months . |